510(k) K033057

DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE by Deroyal — Product Code FYA

K033057 is an FDA 510(k) premarket notification submitted by Deroyal for the device "DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE". The FDA issued a decision of Substantially Equivalent on November 20, 2003. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Deroyal has at least 4 other 510(k) clearances on record.